VRAYLAR is effective and has established safety and tolerability in pediatric patients1
Pediatric Indications
The safety and effectiveness of VRAYLAR have been established in patients 10 years of age and older with manic or mixed episodes of bipolar I disorder1*
- Use of VRAYLAR in this pediatric population is supported by evidence from adequate and well-controlled studies in adults with manic and mixed episodes associated with bipolar I disorder, pharmacokinetic data from adult and pediatric patients, and safety data in pediatric patients 10 to 17 years of age
- In a 52-week, open-label study, 86 of 167 pediatric patients received VRAYLAR for at least 6 months
- Adverse reactions reported in clinical studies for this age group were generally similar to those observed in adult patients
Most Common Adverse Reactions (in ≥5% of participants)2†‡
| Adverse Reactions, n (%) |
BP-I Acute Manic/Mixed (n=146) |
|---|---|
| Weight gain | 20 (13.7) |
| Somnolence | 16 (11.0) |
| Headache | 15 (10.3) |
| Nausea | 14 (9.6) |
| Fatigue | 12 (8.2) |
| Akathisia | 11 (7.5) |
| Agitation | 10 (6.8) |
†Based on final results from a long-term, open-label study in pediatric patients with bipolar I mania or schizophrenia in which all participants received open-label VRAYLAR, with no placebo or comparator group.1
*The safety and effectiveness of VRAYLAR for the treatment of manic or mixed episodes associated with bipolar I disorder have not been established in pediatric patients less than 10 years of age.1
‡Most common adverse events in adult bipolar I manic/mixed episode studies were EPS, akathisia, vomiting, dyspepsia, somnolence, and restlessness.1
Average pediatric weight gain was similar to expectations for this age group§‖¶
To adjust for normal growth, z-scores were derived (measured in standard deviations [SD]), which normalize for natural growth of children and adolescents by comparisons to age- and gender-matched population standards
| Interim Data Analysis BP-I Acute Manic/Mixed1 (n=143) |
Full Data Analysis BP-I Acute Manic/Mixed2# (n=146) |
|
|---|---|---|
| Mean change in weight from baseline** | 6.8 lb | 7.0 lb |
| Mean change in body weight z-score from baseline** | 0.2 SD | 0.0 SD |
| % patients with an increase in body weight z-score ≥0.5 SD | 14.6% | 6.3% |
#Data are consistent with FDA-approved label. A related submission is currently under FDA review.
§Expected weight gain per age- and gender-adjusted population standards based on CDC growth charts for the United States.
‖The use of VRAYLAR in the pediatric population is supported by evidence from adequate and well-controlled studies in adults with schizophrenia or BP-I mania/mixed episodes, pharmacokinetic data from adult and pediatric patients, and safety data in pediatric patients.
¶Recommended dose range of VRAYLAR is 3 mg or 4.5 mg/day for patients 10 to 17 years of age with acute manic or mixed episodes of bipolar I disorder.
**To last available visit.
The safety and effectiveness of VRAYLAR have not been established in pediatric patients under 10 years of age for the treatment of bipolar I mania or mixed episodes.
The safety and effectiveness of VRAYLAR have been established in patients 13 years of age and older with schizophrenia1*
- Use of VRAYLAR in this pediatric population is supported by evidence from adequate and well-controlled studies in adults with schizophrenia, pharmacokinetic data from adults and pediatric patients, and safety data in pediatric patients 13 to 17 years of age
- In a 52-week, open-label study, 86 of 167 pediatric patients received VRAYLAR for at least 6 months
- Adverse reactions reported in clinical studies for this age group were generally similar to those observed in adult patients
Most Common Adverse Reactions (in ≥5% of participants)2†‡
| Adverse Reactions, n (%) |
Schizophrenia (n=21) |
|---|---|
| Weight gain | 3 (14.3) |
| Nausea | 2 (9.5) |
| Vomiting | 2 (9.5) |
| Agitation | 2 (9.5) |
| Akathisia | 2 (9.5) |
| Salivary hypersecretion | 2 (9.5) |
†Based on final results from a long-term, open-label study in pediatric patients with bipolar I mania or schizophrenia in which all participants received open-label VRAYLAR, with no placebo or comparator group.2
*The safety and effectiveness of VRAYLAR for the treatment of schizophrenia have not been established in pediatric patients less than 13 years of age.1
‡Most common adverse reactions from short-term schizophrenia adult studies were EPS and akathisia.1
Average pediatric weight gain was similar to expectations for this age group§‖¶
To adjust for normal growth, z-scores were derived (measured in standard deviations [SD]), which normalize for natural growth of children and adolescents by comparisons to age- and gender-matched population standards
| Interim Data Analysis Schizophrenia1 (n=21) |
Full Data Analysis Schizophrenia2# (n=21) |
|
|---|---|---|
| Mean change in weight from baseline** | 5.3 lb | 5.3 lb |
| Mean change in body weight z-score from baseline** | 0.1 SD | 0.1 SD |
| % patients with an increase in body weight z-score ≥0.5 SD | 0% | 0% |
#Data are consistent with FDA-approved label. A related submission is currently under FDA review.
§Expected weight gain per age- and gender-adjusted population standards based on CDC growth charts for the United States.
‖The use of VRAYLAR in the pediatric population is supported by evidence from adequate and well-controlled studies in adults with schizophrenia or BP-I mania/mixed episodes, pharmacokinetic data from adult and pediatric patients, and safety data in pediatric patients.
¶Recommended dose range of VRAYLAR is 1.5 mg to 4.5 mg/day for patients 13 to 17 years of age with schizophrenia.
**To last available visit.
The safety and effectiveness of VRAYLAR have not been established in pediatric patients under 13 years of age for the treatment of schizophrenia.
CDC=Centers for Disease Control and Prevention; EPS=extrapyramidal symptoms; FDA=U.S. Food and Drug Administration.